New Italian Device Registration Requirements
Dear valued client,
With this newsletter we would like to inform you of the new registration requirements which recently have been implemented for medical devices in Italy. With the approval of the Italian Decree of February 20, 2007 new registration procedures were introduced for class I, IIa, IIb and III products and as well as for systems, kits and active implantable devices. To comply with the new requirements, each medical device placed on the Italian market needs to be registered in the databank of the Italian Ministry of Health by the manufacturer, his European Representative or his distributor. The registration is compulsory and only those devices that are registered will be released for sale to Italian hospitals and public health organizations.
Registration requirements were already in place in Italy for a number of years and it seemed that distributors performed the registration without the knowledge of the manufacturer or they were simply not enforced as such. The registrations that already were performed in Italy before the implementation of the new law will stay valid; however, as of January 1, 2009 public health organizations will not be allowed to purchase the products if they are not registered according to the new regulations.
The below aspects need to be considered in regards to the new requirements.
August 1, 2007: All devices which were first placed on the Italian market after May 1, 2007 need to be registered by August 1, 2007. Otherwise they will not be admitted for sale to public health organizations.
January 1, 2009: All devices that were already placed on the Italian market before May 1, 2007 (and consequently were already inserted into the former Italian device databank) need to be registered by that time. Otherwise the sale to public health organizations will not be possible.
For the purpose of the new regulation the Italian Ministry of Health recently installed a medical device databank that allows the manufacturers or their representative to register the products online. The products need to be registered individually or per product family (i.e. all products that share the same technical file). Apart from a national nomenclature system (CND) the Italian Ministry of Health uses the GMDN code system to identify the corresponding product groups. According to the authority, the registration process needs approximately 3 months to be completed, depending on the lead time at the Ministry of Health. Once the process is finalized, the Ministry of Health will assign a notification number to each registered product/product family.
The applicable registration fees are laid down in the Italian Decree of March 20, 2007. The fees that are charged by the Ministry of Health for the registration of one product/product family amount to € 100, which need to be paid in advance.
The official medical device website of the Italian Ministry of Health is the following: http://www.ministerosalute.it/dispositivi/dispomed.jsp
Most of the information provided by the Italian Ministry of Health is in Italian only. The following link provides some English information on the first steps of the registration process: http://www.ministerosalute.it/dispositivi/paginainterna.jsp?id=395&menu=registrazione
Appoint MDSS to perform the Italian registration on your behalf
As your European Authorized Representative we will be able to perform the Italian product registration on your behalf. To deal with the language barrier we recently hired additional staff that is fluent in Italian and we are currently in the process of evaluating and summarizing the information that will be required for registration.
If you would like MDSS to perform the registration in Italy on your behalf, please feel free to contact us and we will be more than happy to provide you with more detailed information.
Due to the tight registration timeline, we recommend to evaluate as soon as possible whether you would like to have your products registered with the Italian Ministry of Health in order to finalize the process by January 1, 2009.
We hope that the above information is helpful. Certainly we are at your disposal for any further questions you may have regarding this matter
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